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Class II · ModerateRecall completed

Zolpidem Tartrate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: DNE0893A Expires 07/31/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA foreign manufacturer
Brand nameZOLPIDEM TARTRATE
Generic nameZOLPIDEM TARTRATE
Active ingredient(s)ZOLPIDEM TARTRATE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC47335-308-88
Show the full FDA record
Full product labelZolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA
Quantity14,568 bottles
Recall initiated2024-01-18
Report date2024-01-31
Recall completed—
Recall numberD-0272-2024
ClassificationClass II
FDA statusCompleted
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.